Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List
- VernacularTitle:《国家基本药物目录》中的中成药说明书项目若干问题探讨
- Author:
Chunxiao LI
1
;
Jingya SUN
2
;
Xiao LING
1
;
Xuelin LI
1
;
Ya ZHAO
1
;
Bo ZHANG
3
Author Information
1. Dept. of Pharmacy，the First Affiliated Hospital of Henan University of TCM/Henan Province Engineering Laboratory for Clinical Evaluation Technology of TCM，Zhengzhou 450000，China;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of P.R. China，Zhengzhou 450000，China
2. Dept. of Pharmacy，the First Affiliated Hospital of Henan University of TCM/Henan Province Engineering Laboratory for Clinical Evaluation Technology of TCM，Zhengzhou 450000，China;Clinical Pharmacy Department，Luanchuan County Hospital of TCM，Henan Luoyang 471500，China
3. Dept. of Pharmacy，the First Affiliated Hospital of Henan University of TCM/Henan Province Engineering Laboratory for Clinical Evaluation Technology of TCM，Zhengzhou 450000，China
- Publication Type:Journal Article
- Keywords:
National Essential Medicine List;
Chinese patent medicine instruction;
Rational drug use;
Medication for special
- From:
China Pharmacy
2021;32(13):1616-1622
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions.
